Status:
RECRUITING
The Impact of Overnight Nutrition Support on Sleep and Circadian Rhythm Disruption in the ICU
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Feeding Patterns
Sleep
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to determine whether modifying the timing of nutrition support from overnight to daytime enhances sleep quality, preserves circadian rhythms, and improves overall inflamma...
Detailed Description
Intensive care unit (ICU) environments do not support sleep or preserve circadian rhythms of postoperative critically ill patients. Among the contributing factors is the common practice of administeri...
Eligibility Criteria
Inclusion
- Adult male or non-pregnant female volunteers (age 18+)
- Scheduled for a cardiac surgical procedure with planned post-operative admission to the ICU for \>48 hours
- Able and willing to give consent and comply with study procedures
Exclusion
- Blind, deaf or unable to speak English
- Women who are pregnant or nursing
- Contraindications to safe use enteral nutrition, including gastrointestinal obstruction
- Personal history of intestinal malabsorption, gallbladder disease or pancreatitis
- Dietary restrictions precluding enteral feeds
- Renal and liver failure requiring dialysis or Child-Pugh score \> 7
- Severe deficit due to structural or anoxic brain damage
- With skin condition that precludes wearing sensors
Key Trial Info
Start Date :
February 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04737200
Start Date
February 8 2022
End Date
March 31 2026
Last Update
May 8 2025
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114